Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- The difference of rate of estimated glomerular filtration rate (eGFR) decline
研究概览
简要总结
If primary health-care officers and Villages Health Volunteers (VHVs) be trained to render proper CKD care, it is interesting if their intimate relationship and commitment to their responsible village households will result in better outcomes when compared with the conventional care model as mention above. In this project, we plan to compare the effectiveness of a conventional care program against an integrated multidisciplinary CKD care program provided by nephrologists in conjunction with well-trained paramedical personnel and VHVs on CKD progression.
详细描述
Background The unique characteristic of community-health care in Thailand is a system of primary- health care officers and Village Health Volunteers (VHVs) providing basic health care to more than 90% of Thai population. Should these allied personnel be trained on how to render proper chronic kidney disease (CKD) care, it would be interesting to study whether their role play care will result in better quality of CKD care.
Design This study is a community-based cluster randomized controlled trial to be conducted in 2 districts of Kamphaeng Phet Province, located about 400 kilometers north of Bangkok. About 300 stage 3-4 CKD patients will be enrolled to each of the 2 treatment groups. Patients in both groups will be treated according to The National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines. The District 1 (control group) patients will be provided a conventional CKD care. For the District 2 (intervention group) patients, an integrated CKD care program will be provided by the multidisciplinary team of district hospital in conjunction with the community CKD care networks (i.e. primary-health care officers and VHVs). The key activities of integrated CKD care program are live demonstration about treatment and optimal diets for CKD patients which will be provided during each hospital visit and quarterly home visits. Clinical and laboratory parameters of all cases will be assessed every 3 months. Duration of the study is 24 months. The primary outcome of this study is the rate of eGFR decline. The secondary outcomes are time of initiation of dialysis, cardiovascular mortality, and all-cause mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18-70 years and known to have diabetes and/or hypertension.
- •eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.
排除标准
- •unstable/advanced cardiovascular disease
- •active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).
研究组 & 干预措施
Integrated Chronic Kidney Disease care
standard guidelines of CKD treatment + Integrated CKD care consisting of multidisciplinary team care and home visit by community care network
干预措施: Integrated Chronic Kidney Disease care (Behavioral)
Conventional CKD care
standard guidelines of CKD treatment
干预措施: Conventional CKD care (Behavioral)
结局指标
主要结局
The difference of rate of estimated glomerular filtration rate (eGFR) decline
时间窗: 30 months
We compare the difference of rate of estimated glomerular filtration rate (eGFR) decline between intervention group and control group from baseline to the end of the study.
次要结局
- Cardiovascular Morbidity or Event(24 months)
- Incidence of Initiation of Renal Replacement Therapy(24 months)
- Hospitalization(24 months)
- Change from baseline in Systolic Blood Pressure at 24 months(24 months)
- Change from baseline in amount of proteinuria at 24 months(24 months)
- Change from Baseline in Hemoglobin A1C at 24 months(24 months)
- Change from baseline in 24 hour urine sodium at 24 months(24 months)
- Change from baseline in Protein Intake at 24 months(24 months)
研究者
Dr.Teerayut Jiamjariyaporn
Principal Investigator, Nephrologist
Bhumirajanagarindra Kidney Institute, Thailand